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Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice

RECRUITINGSponsored by Outcomes'10
Actively Recruiting
SponsorOutcomes'10
Started2025-11-20
Est. completion2026-10
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

The objective of this observational study is to characterize the patient profile and nutritional treatment patterns of individuals with type 2 diabetes (T2D) or drug-induced diabetes who present with malnutrition, or are at risk of it, and who are prescribed a diabetes-specific oral nutritional supplement (ONS) that is high in calories and protein and contains soluble fiber. Participants will complete a series of questionnaires during visits 1 and 3.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Adult patients diagnosed with type 2 diabetes (T2D) or drug-induced diabetes
* Patients at nutritional risk according to MUST or presenting malnutrition according to GLIM criteria.
* Patients requiring a diabetes-specific oral nutritional supplement (ONS) that is high-calorie, high-protein, and contains soluble fiber in real-world clinical practice, and who have been prescribed such a supplement within the previous 7 days.
* Patients able to provide informed consent and complete the study questionnaires.

Exclusion Criteria:

* Patients participating in other studies or clinical trials related to malnutrition, or who, in the investigator's opinion, may alter the course of the study.
* Patients currently receiving or expected to receive other types of nutritional interventions involving supplements (oral or otherwise) or non-conventional feeding methods (e.g., feeding tubes).
* Patients with a history of metabolic/endocrine diseases (other than diabetes) or any other condition causing liver or kidney failure, defined as ALT \> 3x ULN or eGFR \< 30 ml/min/1.73 m², and according to the investigator's judgment.
* Patients expected to undergo any surgical intervention or require hospitalization due to a condition unrelated to the study during the study period.
* Patients with other conditions that, in the investigator's opinion, may interfere with adherence to the intervention or with study procedures.

Conditions5

DiabetesDrug-Induced DiabetesMalnourishmentMalnutritionType 2 Diabetes Mellitus (T2DM)

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